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IEC 63077
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Good refurbishment practices for medical imaging equipment
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
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IEC 63077
Edition 1.0 2019-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Good refurbishment practices for medical imaging equipment
Bonnes pratiques de reconditionnement pour les appareils d’imagerie médicale
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55 ISBN 978-2-8322-7595-5
– 2 – IEC 63077:2019 © IEC 2019
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 General requirements for REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT . 9
4.1 Quality management system . 9
4.2 Resource management . 9
4.3 Corrective and preventive action . 9
4.4 Customer complaints . 9
4.5 Production and service provision . 9
4.6 Control of nonconforming PRODUCT . 10
4.7 Post-market surveillance PROCESS . 10
4.8 Document control . 10
4.9 Purchasing . 10
4.10 Control of design and design changes . 10
4.11 RISK management PROCESS . 10
5 Specific requirements for good REFURBISHMENT practice . 11
5.1 General . 11
5.2 Selection of MEDICAL IMAGING EQUIPMENT for REFURBISHMENT . 11
5.3 Evaluating market access requirements . 11
5.4 Preparation for REFURBISHMENT, disassembly, packing, and transport . 11
5.5 Planning . 11
5.6 Installation of software and hardware to ensure the safety of the MEDICAL
IMAGING EQUIPMENT . 12
5.7 Performance and safety test . 12
5.8 Packing, transport, and installation of refurbished MEDICAL IMAGING
EQUIPMENT. 12
5.9 Record of REFURBISHMENT . 12
5.10 REFURBISHMENT label . 12
Annex A (informative) Cross reference list of the contents of IEC 63077 versus
ISO 13485 . 13
Bibliography . 15
Index of defined terms used in this document . 16
Table A.1 – Cross reference list of the contents of IEC 63077 versus ISO 13485 . 13
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
FOREWORD
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International Standard IEC 63077 has been prepared by subcommittee 62B: Diagnostic
imaging equipment, of IEC technical committee 62: Electrical equipment in medical practice.
This first edition cancels and replaces the second edition of IEC PAS 63077 published in 2016.
This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC PAS
63077:2016:
a) the scope was delineated more clearly;
b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added;
c) smaller corrections were performed.
– 4 – IEC 63077:2019 © IEC 2019
The text of this International Standard is based on the following documents:
FDIS Report on voting
62B/1149/FDIS 62B/1155/RVD
Full information on the voting for the approval of this International Standard can be found in
the report on voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
– requirements and definitions: roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
– TERMS DEFINED IN CLAUSE 3: SMALL CAPITALS.
The committee has decided that the contents of this document will rem
...